The long-term objective of this project is to develop guidance on the disclosure of results from genetic research studies to participating patients and/or volunteers in order to facilitate the responsible translation of genetic information to improved human health. Although there is general agreement that researchers need to indicate their disclosure plans as part of the informed consent process, the ethical, legal and social considerations that should inform the decision to disclose (or not) remain unclear to many researchers. The specific aims of this project are to address this void by performing a systematic evaluation of relevant regulatory guidelines and bioethical perspectives, with the goal of informing policy. Underlying principles, areas of agreement, and controversy will be identified through: content analysis of extant literature and reports; key informant interviews with representatives from relevant federal agencies, professional, advisory and advocacy groups; survey questionnaires of local IRBs. These data will form the basis for a draft set of guidelines, whose feasibility will be evaluated by applying them to a spectrum of ongoing genetic research studies at Case, including Mendelian disease (Huntington's Disease) and complex chronic diseases (family sibling study of colorectal cancer; Alzheimer's disease intervention study; biobank study of cardiovascular disease) involving affected and unaffected individuals, as well as family members. Resulting draft guidelines will be critiqued by an expert panel (External Advisory Group) for their utility on a national level. The results of this effort will support the development of an R01 grant application to test the guidelines nationally. [unreadable] [unreadable] Public Statement: Overall, this grant will address ethical, legal and social factors that influence the translation of genetic information to improved human health, especially in the context of exploring ethical ways to conduct cutting edge genetic and genomic research that involves human participants. The grant will focus on issues related to the disclosure of results from genetic research studies-that is, if, when, and under what conditions should the results of genetic research studies, including incidental findings, be disclosed to the individual, his/her family, or his/her physician. [unreadable] [unreadable] [unreadable]